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Lumina Smart
EUDAMEDClass I (EU MDR)
Ref 6580030Model CuringPen, KIRA, Lumina Smart
Identity
- Trade Name
- Lumina Smart EUDAMED
- Device Name
- Dental Curing Light EUDAMED
- Model / Reference
- CuringPen, KIRA, Lumina Smart EUDAMED6580030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972597781898 EUDAMED
- Basic UDI-DI
- 697259778EL001M9 EUDAMED
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Lumina Smart by Changzhou Sifary Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697259778EL001M9 | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Sifary Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010405
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 322091e1-fc48-4130-9a4b-c2641036750f 61 fields · synced Jul 21, 2026